OSMOSOL-R- multiple electrolyte injection type 1 injection, solution
OsmoSol-R by
Drug Labeling and Warnings
OsmoSol-R by is a Animal medication manufactured, distributed, or labeled by MWI (VetOne), Nova-Tech, Inc., Macco Organiques Inc, Zhejiang Ruibang laboratories. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
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INFORMATION FOR OWNERS/CAREGIVERS
Assembled in U.S.A.
Manufactured for:
MWI, Boise, ID 83705
www.VetOne.netNDC: 86136-008-05
V1 501206
5000 mL (169.07 fl oz)
18-827
RMS# 92-2123
Iss. 08/21
- VETERINARY INDICATIONS
- KEEP OUT OF REACH OF CHILDREN
- CAUTION:
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Active Ingredients:
Each 100 mL contains Sodium Chloride 526 mg; Sodium Acetate 222 mg; Sodium Gluconate 502 mg; Potassium Chloride 37 mg; Magnesium Chloride 30 mg in water for Injection. May contain HCl or NaOH for pH adjustment.
mEq/liter: Sodium 140; Potassium 5; Magnesium 3; Chloride 98; Acetate 27; Gluconate 23.
Osmolarity: 294 mOsmol/liter (calc).
pH: 7.4 (6.5 - 8.0).
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CAUTION:
Sterile nonpyrogenic solution. Use only if solution is clear and container is undamaged. This is a single dose unit. For Intravenous or subcutaneous use. It contains no preservatives. Use promptly upon initial entry. If entire contents are not used, discard unused portion. Must not be used in series connections. Additives may be incompatible. Squeeze and inspect inner bag which maintains product sterility. Discard if leaks are found or if the solution contains visible solid particles.
- Usual dose:
- STORAGE:
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Description:
OsmoSol-R 7.4 is a sterile, nonpyrogenic isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of OsmoSol-R 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, 30 mg. May contain HCL and/or NaOH for pH adjustment. pH 7.4 (6.5 - 8.0); 294 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. OsmoSol-R 7.4 is a parenteral fluid and electrolyte replenisher.
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Adverse Reactions:
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deeemed necessary.
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Indications:
OsmoSol-R 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. OsmoSol-R 7.4 can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. OsmoSol-R 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.
- Contraindications:
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Precautions:
OsmoSol-R 7.4 should be used with caution in severe renal impairment because of the danger of hyperkalemia. As with all intravenous solutions, care should be taken to avoid circulatory overload, especially in patients with cardiac or pulmonary disorders. OsmoSol-R 7.4 is not intended to correct acidosis or large deficits of individual electrolytes, nor to replace blood or plasma expanders when these are indicated. Do not administer unless solution is clear and container is undamaged. Discard unused portion. Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions containing acetate or gluconate ions should be used with caution, as excess administration may result in metabolic alkalosis.
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Warnings:
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Solutions which contain potassium should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing acetate or gluconate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate or gluconate should be administered with great care in those conditions in which there is an increased level or an impaired initialization of these ions, such as severe hepatic insufficiency. The intravenous administration of this solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk if solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.
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Dosage and Administration:
Administer by intravenous infusion. It may also be administered subcutaneously. The amount to be infused is based on replacement of losses of extracellular fluid volume in the individual patient. Up to 3 times the volume of estimated blood loss during and after surgery can be given to correct ciruculatory volume when there is only a moderate loss of blood.
- Overdosage:
- Warnings:
- INFORMATION FOR OWNERS/CAREGIVERS
- VETERINARY INDICATIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OSMOSOL-R
multiple electrolyte injection type 1 injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 86136-008 Route of Administration INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 526 mg in 100 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION 37 mg in 100 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 30 in 100 mL SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (ACETATE ION - UNII:569DQM74SC) SODIUM ACETATE ANHYDROUS 222 in 100 mL SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B) SODIUM GLUCONATE 502 in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 86136-008-05 5000 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/23/2022 Labeler - MWI (VetOne) (019926120) Registrant - MWI (VetOne) (019926120) Establishment Name Address ID/FEI Business Operations Nova-Tech, Inc. 196078976 manufacture, analysis Establishment Name Address ID/FEI Business Operations Macco Organiques Inc 246200364 api manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Ruibang laboratories 544807456 api manufacture
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